Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics
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|ClinicalTrials.gov Identifier: NCT01939288|
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : January 10, 2014
What is known?
- Disorders of peripheral circulation result in vascular morbidity and mortality
- Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease
- The benefit of intermittent pneumatic compression is clinically well evidenced.
- The use of intermittent pneumatic compression is limited by compliance issues related to sleeve application and external power source.
What new information will this trial contribute?
- This evaluates the haemodynamic effect of a new electrical device for augmentation of peripheral circulation
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects Intermittent Pneumatic Compression Versus Neuromuscular Electrical Stimulation||Device: Neuromuscular stimulator followed by IPC Device: IPC followed by neuromuscular stimulator||Not Applicable|
RATIONALE - Enhancement of peripheral circulation has been shown to be of benefit in many vascular disorders, and the clinical effectiveness of intermittent pneumatic compression (IPC) is well established in peripheral vascular disease.
OBJECTIVE - This study aims to compare the haemodynamic efficacy of a novel neuromuscular electrical stimulation (NMES) device with IPC in healthy subjects.
METHODS - 10 healthy volunteers will be randomised into two groups, in an interventional cross-over trial. Baseline measurements of haemodynamic velocity and flow will be taken, then subjects given bilateral therapy with each of the two devices in turn. Laser doppler fluximetry readings will be taken from the hand and foot. Baseline readings will be compared with readings taken after immediate cessation of therapy, and after 10 minutes. Tolerability will be measured using a verbal reported score.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Group 1
Half of recruited subjects (n=5)
Device: Neuromuscular stimulator followed by IPC
Other Name: Device 1 followed by a break, followed by device 2
Experimental: Group 2
Other half of recruited subjects (n=5)
Device: IPC followed by neuromuscular stimulator
Other Name: IPC as device one, followed by a short break then to receive neuromuscular stimulator
- Haemodynamic flow [ Time Frame: One day ]Composite ultrasound measurements of venous and arterial peak velocity, time averaged maximum velocity, and flow rate. This is taken from the left leg superficial femoral vein and artery
- Laser doppler fluximetry [ Time Frame: One day ]Laser doppler readings will be taken from the left foot and hand of subjects whilst undergoing the protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939288
|Academic Vascular Surgery, Charing Cross Hospital|
|London, United Kingdom, W6 8RF|